药品注册申请号:050420
申请类型:NDA (新药申请)
申请人:SANOFI AVENTIS US
申请人全名:SANOFI AVENTIS US LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 RIFADIN RIFAMPIN CAPSULE;ORAL 300MG Yes No None 1971/05/21 Approved Prior to Jan 1, 1982 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2023/12/08 SUPPL-91(补充) Approval Labeling STANDARD
2023/08/16 SUPPL-90(补充) Approval Labeling STANDARD
2023/02/17 SUPPL-89(补充) Approval Labeling STANDARD
2023/02/10 SUPPL-88(补充) Approval Labeling STANDARD
2022/01/29 SUPPL-87(补充) Approval Labeling STANDARD
2021/10/21 SUPPL-86(补充) Approval Labeling STANDARD
2021/06/17 SUPPL-85(补充) Approval Labeling STANDARD
2020/05/12 SUPPL-84(补充) Approval Labeling STANDARD
2019/08/27 SUPPL-83(补充) Approval Labeling STANDARD
2019/02/28 SUPPL-80(补充) Approval Labeling STANDARD
2019/01/23 SUPPL-78(补充) Approval Labeling STANDARD
2018/01/08 SUPPL-77(补充) Approval Labeling STANDARD
2017/04/24 SUPPL-76(补充) Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2013/02/27 SUPPL-75(补充) Approval Labeling STANDARD
2010/11/10 SUPPL-73(补充) Approval Labeling STANDARD
2004/08/20 SUPPL-72(补充) Approval Labeling STANDARD
2000/04/12 SUPPL-71(补充) Approval Labeling STANDARD
2000/04/12 SUPPL-70(补充) Approval Labeling STANDARD
1996/09/17 SUPPL-67(补充) Approval Labeling STANDARD
1996/01/05 SUPPL-64(补充) Approval Manufacturing (CMC)
1995/09/05 SUPPL-68(补充) Approval Manufacturing (CMC)
1994/07/12 SUPPL-66(补充) Approval Manufacturing (CMC)
1993/06/18 SUPPL-63(补充) Approval Labeling
1990/02/12 SUPPL-9(补充) Approval Manufacturing (CMC)
1990/02/12 SUPPL-7(补充) Approval Labeling
1989/05/18 SUPPL-13(补充) Approval Manufacturing (CMC)
1987/11/16 SUPPL-14(补充) Approval Manufacturing (CMC)
1986/02/18 SUPPL-11(补充) Approval Manufacturing (CMC)
1984/09/12 SUPPL-12(补充) Approval Labeling
1984/02/08 SUPPL-10(补充) Approval Manufacturing (CMC)
1983/09/02 SUPPL-8(补充) Approval Labeling
1982/11/17 SUPPL-5(补充) Approval Manufacturing (CMC)
1982/11/15 SUPPL-4(补充) Approval Manufacturing (CMC)
1982/11/15 SUPPL-3(补充) Approval Manufacturing (CMC)
1982/10/26 SUPPL-2(补充) Approval Manufacturing (CMC)
1982/10/05 SUPPL-1(补充) Approval Manufacturing (CMC)
1982/09/11 SUPPL-59(补充) Approval Manufacturing (CMC)
1982/03/22 SUPPL-18(补充) Approval Labeling
1981/10/20 SUPPL-61(补充) Approval Manufacturing (CMC)
1981/10/20 SUPPL-60(补充) Approval Labeling
1980/12/31 SUPPL-58(补充) Approval Manufacturing (CMC)
1980/07/25 SUPPL-57(补充) Approval Manufacturing (CMC)
1979/10/29 SUPPL-56(补充) Approval Manufacturing (CMC)
1979/10/25 SUPPL-55(补充) Approval Manufacturing (CMC)
1979/07/25 SUPPL-54(补充) Approval Labeling
1979/06/26 SUPPL-49(补充) Approval Labeling
1979/05/01 SUPPL-53(补充) Approval Labeling
1979/04/16 SUPPL-52(补充) Approval Labeling
1979/04/16 SUPPL-51(补充) Approval Manufacturing (CMC)
1979/03/23 SUPPL-50(补充) Approval Labeling
1978/06/29 SUPPL-48(补充) Approval Labeling
1978/05/30 SUPPL-47(补充) Approval Labeling
1978/02/10 SUPPL-46(补充) Approval Labeling
1977/06/29 SUPPL-45(补充) Approval Labeling
1977/05/25 SUPPL-6(补充) Approval Manufacturing (CMC)
1976/12/21 SUPPL-44(补充) Approval Labeling
1976/08/09 SUPPL-43(补充) Approval Manufacturing (CMC)
1976/08/03 SUPPL-42(补充) Approval Manufacturing (CMC)
1976/03/29 SUPPL-37(补充) Approval Labeling
1976/03/01 SUPPL-41(补充) Approval Manufacturing (CMC)
1976/02/18 SUPPL-40(补充) Approval Labeling
1976/01/28 SUPPL-39(补充) Approval Labeling
1976/01/19 SUPPL-38(补充) Approval Labeling
1975/10/15 SUPPL-35(补充) Approval Manufacturing (CMC)
1975/09/16 SUPPL-34(补充) Approval Labeling
1975/08/28 SUPPL-36(补充) Approval Manufacturing (CMC)
1975/01/30 SUPPL-33(补充) Approval Labeling
1974/11/26 SUPPL-32(补充) Approval Labeling
1974/05/29 SUPPL-30(补充) Approval Labeling
1974/05/21 SUPPL-31(补充) Approval Labeling
1974/03/28 SUPPL-29(补充) Approval Manufacturing (CMC)
1974/03/28 SUPPL-28(补充) Approval Labeling
1974/01/24 SUPPL-27(补充) Approval Labeling
1973/11/20 SUPPL-25(补充) Approval Labeling
1973/10/11 SUPPL-26(补充) Approval Labeling
1973/05/09 SUPPL-24(补充) Approval Manufacturing (CMC)
1973/01/19 SUPPL-23(补充) Approval Labeling
1972/10/05 SUPPL-22(补充) Approval Manufacturing (CMC)
1972/09/25 SUPPL-21(补充) Approval Labeling
1972/08/31 SUPPL-20(补充) Approval Manufacturing (CMC)
1972/06/16 SUPPL-19(补充) Approval Manufacturing (CMC)
1972/01/26 SUPPL-17(补充) Approval Labeling
1971/12/06 SUPPL-16(补充) Approval Manufacturing (CMC)
1971/08/09 SUPPL-15(补充) Approval Labeling
1971/05/21 ORIG-1(原始申请) Approval UNKNOWN
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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